Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

NCT07352852 | Recruiting

• 1 other identifier: Bridge-2024-04-CIP-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a prospective, multicenter, single-arm study. About 300 subjects undergoing rapamycin-eluting stent implantation will be enrolled based on the inclusion and exclusion criteria. The primary endpoint is the rate of any stroke or death within 1 month. Secondary efficacy endpoints include immediate stent implantation success. Safety endpoints cover the incidence of stroke or neurological death, target-vessel-related stroke or death, all-cause mortality, and mRS scores at 12-month follow-ups. Subjects will be clinically followed up before surgery, device implantation, discharge, and at 1, 6, and 12 months post-surgery. An imaging subgroup of at least 80 subjects who agree to DSA follow-up at 12 months will assess in-stent restenosis (\>50%).

Conditions

Intracranial Arterial Stenosis; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of any stroke or death within 1 month after the procedure

  1 month

Secondary Outcomes (6)

• Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)

  1 year

• Immediate techenical success rate of stent implantation (imaging subgroup)

  immediately after the intervention

• Incidence of stroke or neurogenic death within 1-year follow-up

  1 year

• Incidence of target vessel-related stroke or death within 1-year follow-up

  1 year

• All-cause mortality within 1-year follow-up

  1 year

Study Arms (1)

exposed group

subjects undergoing rapamycin-eluting stent implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing rapamycin-eluting stent implantation

You may qualify if:

• Age ≥18 and ≤80 years;
• Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment;
• Digital subtraction angiography (DSA) shows target lesion stenosis ≥70%;
• Suitable for implantation of rapamycin-targeted drug-eluting stents;
• The patient and/or their authorized representative can understand the study purpose, agree to participate, and sign the informed consent form.

You may not qualify if:

• Modified Rankin Scale (mRS) score ≥3;
• Ischemic stroke within the past 2 weeks;
• Presence of more than 2 intracranial atherosclerotic stenosis lesions requiring interventional treatment;
• Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs, and inability to tolerate anticoagulant/antiplatelet therapy;
• Severe dysfunction of major organs (e.g., severe hepatic insufficiency, renal insufficiency, heart failure);
• Severe allergies to contrast agents, rapamycin and its derivatives, cobalt-based alloys, or polylactic acid;
• Pregnant or lactating women;
• Participation in other drug or device studies without reaching the endpoint;
• Life expectancy less than 12 months;
• Lesions or vascular access deemed unsuitable for rapamycin drug-eluting stent implantation by the operator.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yong Zhang

CONTACT

(+86) 18661818866; bravezhang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Neurointerventional Medicine, The Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)